Under the MOU, the two entities agreed to share information to “facilitate the development of innovative products, including medical countermeasures,” such as diagnostics, vaccines, and therapeutics to combat disease transmission during a pandemic.
Experts are concerned that the Gates Foundation could have undue influence over the FDA’s regulatory decisions of these countermeasures.
David Gortler, an ex-senior adviser to the FDA commissioner between 2019 and 2021, says he is “suspicious” of the MOU.
“If the Gates Foundation establishes an MOU with a regulator on a product they want to develop, it seems like it would be a conflict of interest. What if every other drug company did the exact same thing as the Gates Foundation?” he says.
Gortler, now a fellow at the Ethics and Public Policy Center in Washington, D.C., explained that normally, meetings between developers and regulators are supposed to be an official part of the public record and subject to Freedom of Information Act requests.
“However, an MOU such as this can circumvent the usual requirements for the transparency of official communications,” says Gortler. “This way their communications can be kept secret.”
David Bell, a former medical officer for the World Health Organisation (WHO) who now works as a public health physician and biotech consultant, agrees that the MOU has potential to corrupt the regulatory process.
“The narrative is that philanthropic foundations can only be good, because they’re making vaccines and saving thousands of lives, so we need to cut the red tape and help the FDA get stuff done quickly otherwise children will die,” says Bell. “But in reality, it has potential to corrupt the whole system.”
Revolving Door
The FDA has been roundly criticised for its “revolving door.” Ten of the past 11 FDA commissioners left the agency and secured roles with pharmaceutical companies they once regulated.Similarly, the Gates Foundation hired high-ranking members of the FDA, who bring with them intimate knowledge of the regulatory process.
Bell has no doubt that these appointments were strategic to “game the system” saying, “If I worked at the Gates Foundation, I would certainly hire somebody like Murray Lumpkin.”
The only way to fix the revolving door problem, Bell says, is to have a “non-compete clause” in their contracts.
“It might be that FDA employees cannot work for the people they’ve regulated for at least 10 years. There are places that have those rules—private companies have agreements that you can’t work for a rival,” said Bell.
“FDA regulatory decision making is science-based. Former FDA officials do not impact regulatory decisions. FDA only collaborates with the Bill and Melinda Gates Foundation under the MOU as described.”
Gates Has Billions at Stake
Gates boasted about receiving a 20-to-1 return on his $10 billion investment into the “financing and delivery” of medicines and vaccines.In September 2019, just prior to the pandemic, Securities and Exchange Commission (SEC) filings showed the foundation purchased over 1 million shares in BioNTech (Pfizer’s partner) for $18.10/share. By November 2021, the foundation dumped most of the stock for an average of $300/share.
Several weeks later when the COVID-19 pandemic emerged, many aspects of this “hypothetical scenario” became a chilling reality.
Global Dominance
The Gates Foundation has poured millions into funding NGOs, media, and international agencies, earning Gates significant political clout.Presidential candidate Robert F. Kennedy Jr. labelled Gates “the most powerful man in public health” because he managed to steer the WHO’s pandemic strategy to focus primarily on vaccination.
“I think [Gates] believes that he is somehow ordained divinely to bring salvation to the world through technology,” said Kennedy. “He believes the only path to good health is inside a syringe.”
The Gates Foundation’s CEO Mark Suzman responded to concerns that the foundation has “disproportionate sway in setting national and global agendas, without any formal accountability to voters or international bodies.”
“But make no mistake—where there’s a solution that can improve livelihoods and save lives, we’ll advocate persistently for it. We won’t stop using our influence, along with our monetary commitments, to find solutions.”